Anton Lesaca focuses his practice on regulatory matters involving the US Food and Drug Administration (FDA) and other regulatory authorities at the federal and state level.
Anton leverages his substantive experience as a former regulator at FDA in providing fulsome and actionable advice regarding the regulation of FDA-regulated products, including foods, dietary supplements, cosmetics, and drugs. He also has experience with regulatory considerations for general consumer products, including FTC regulation of product marketing and promotion and CPSC regulation of product safety standards.
In particular, his expertise in the regulation of medical devices and working knowledge of the Center for Devices and Radiological Health (CDRH) allows him to lend in-depth understanding of and formulate strategies for clients as to the legal, procedural, and practical elements of interacting with FDA from premarket development through product submission, post-market monitoring, and responses to FDA advisory actions and product recalls.
Anton also has experience with digital health clients, particularly those engaged in the development and marketing of software as a medical device (SAMD) and AI-enabled devices, and with the import and export of FDA-regulated articles.
Before joining Latham, Anton served as Associate Chief Counsel in the Office of the Chief Counsel at FDA where he principally advised CDRH on the development and implementation of regulatory policies, guidance documents, rulemaking, legislative efforts, and advisory actions related to medical devices. He also served as counsel of record for FDA in several tobacco civil money penalty cases before the Department of Health and Human Services Departmental Appeals Board. During his tenure in public service and in recognition of his efforts advising FDA on several novel and complex legal matters, he received the FDA Office of the Commissioner’s Outstanding Service Award, CDRH Visionary Recognition Award, and a Commissioner’s Special Citation.
Previously, Anton also worked as a regulatory associate at a large law firm counseling emerging and middle-market companies on FDA, Federal Trade Commission, Consumer Product Safety Commission, Environmental Protection Agency, and state regulatory agency matters.